Therapy in Amyotrophic Lateral Sclerosis (TAME)

• Register: ClinicalTrials.gov
• Last refreshed on: 8 November 2021
• Main ID: NCT02118727
• Date of registration: 15/04/2014
• Prospective Registration: Yes
• Primary sponsor: University of Kansas Medical Center
• Public title: Therapy in Amyotrophic Lateral Sclerosis (TAME) TAME
• Scientific title: Multi-centered Double Blind, Placebo Controlled Study Evaluating the Safety and Efficacy of Memantine at 20 mg BID in Patients With ALS
• Date of first enrolment: November 7, 2018
• Target sample size: 90
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02118727
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

United States

Contacts

• Name: Richard D Barohn, MD
• Affiliation: University of Kansas Medical Center

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Age 18-85

2. Male or Female

3. Clinically definite, probable, probable lab-supported, or possible ALS by El Escorial
criteria

4. ALSFRS-R > 25

5. Must be willing to undergo longitudinal blood draws for biomarker analysis

6. Must have a caregiver

7. Availability and willingness to complete the study

8. Capable of providing informed consent and complying with trial procedures

9. If patients are taking riluzole and/or Radicava, they must be a on a stable dose for
at least thirty days prior to the baseline.

Exclusion Criteria:

1. Patients with FVC = 60%

2. History of liver disease

3. Severe renal failure

4. History of intolerance to memantine

5. Onset of weakness for greater than 3 years

6. Any other co-morbid condition which would make completion of the trial unlikely

7. If female, pregnant or breast-feeding; or, if of childbearing age, an unwillingness to
use birth control.

8. Taking any trial medications. Non-trial medications are not cause for exclusion.

9. Unwillingness to provide consent



Age minimum: 18 Years
Age maximum: 85 Years
Gender: All

Health Condition(s) or Problem(s) studied

Frontal Temporal Dementia

Amyotrophic Lateral Sclerosis

Intervention(s)

Drug: Placebo (for Memantine)

Drug: Memantine

Primary Outcome(s)

Disease progression as measured by the number of points lost on the ALS Functional Rating-Scale-Revised (ALSFRS-R) [Time Frame: During 36 weeks of therapy]

Secondary Outcome(s)

Measuring the levels of Tau, pNFH and the pNFH/C3 ratio in blood [Time Frame: 36 weeks of treatment]

Secondary ID(s)

FDA

TAME-ALS FD003937-01

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

University of Missouri-Columbia